MAR-APREMILAST TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

APREMILAST; APREMILAST; APREMILAST

제공처:

MARCAN PHARMACEUTICALS INC

ATC 코드:

L04AA32

INN (국제 이름):

APREMILAST

복용량:

10MG; 20MG; 30MG

약제 형태:

TABLET

구성:

APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

제품 요약:

Active ingredient group (AIG) number: 0356230001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-11-14

제품 특성 요약

_Page 1 of 35 _
PRODUCT MONOGRAPH
PR
MAR-APREMILAST
apremilast tablets
10 mg, 20 mg, and 30 mg
Selective Immunosuppressant
MARCAN PHARMACEUTICALS INC.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
SUBMISSION CONTROL NO.: 246219
DATE OF PREPARATION:
June 22, 2022
_Page 2 of 35 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
....................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
...........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................................
13
OVERDOSAGE
.....................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY...........................................................................
14
STORAGE AND STABILITY
...................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 17
PART II: SCIENTIFIC INFORMATION
...................................................................................
18
PHARMACEUTICAL INFORMATION
.....................................................................................
18
CLINICAL TRIALS
.............................................................